OncRef
Skip to newsletter content
|
Breast cancerMay 2026
0:00 / 3:34
Breast Cancer — Monthly Compass
May 01–31, 2026 • Priority Updates • 3–5 minute read
 
A curated, practice-minded digest of what moved in breast cancer this month — regulatory signals, clinical development, and the most practice-relevant publications.
Built for oncologists OncRef Curated Oncology Intelligence Layer
breast cancer updates
Key Highlights
Key Highlights
  • Practice-Changing Updates
    • Between May 1 and May 22, 2026, FDA approvals redefined standards across subtypes: vepdegestrant (Veppanu) for ESR1‑mutated ER+/HER2– advanced/metastatic disease after endocrine therapy progression (May 1), Enhertu for neoadjuvant Stage II–III and adjuvant residual‑disease HER2‑positive early breast cancer (May 15), and datopotamab deruxtecan (Datroway) for first‑line unresectable/metastatic TNBC in patients ineligible for PD‑1/PD‑L1 inhibitors (May 22).
    • Enhertu’s adjuvant application and Datroway both received Priority Review and were evaluated under Project Orbis using FDA’s Assessment Aid, accelerating access in curative‑intent HER2+ disease and immunotherapy‑ineligible first‑line TNBC.
  • Key Clinical Development Updates
    • FDA accepted Celcuity’s NDA for gedatolisib in HR+/HER2–/PIK3CA wild‑type advanced breast cancer with Priority Review and a July 17, 2026 PDUFA date, following Type B meeting alignment on VIKTORIA‑2 Phase 3 amendments and internal preparations for a potential Q3 2026 launch.
    • BriaCell obtained IND clearance to initiate the Phase 1/2a Bria‑BRES+ study and received a DSMB recommendation to continue its pivotal Fast Track Phase 3 program in metastatic breast cancer, while Olema reported FDA Fast Track for palazestrant (OP‑1250) in ER+/HER2– metastatic disease and ongoing Phase 1 enrollment for the KAT6 inhibitor OP‑3136 after IND clearance.
  • Key Conference Updates
    • ASCO 2026 and ESMO Breast 2026 underscored earlier endocrine intensification with oral SERDs—giredestrant showing consistent efficacy across menopausal subgroups in lidERA and activity in persevERA/evERA combinations—and neoadjuvant (Z)-endoxifen plus goserelin targeting ER and PKC/AKT biology in premenopausal ER+/HER2– cohorts.
    • Data emphasized ADC differentiation beyond T‑DXd with the first‑in‑class TROP2/HER3 bispecific JSKN016 for heterogeneous HER2‑negative tumors and highlighted topo‑I cross‑resistance via limited Trodelvy + trastuzumab activity post‑Enhertu (SATEEN), while HER2+ programs evaluated tucatinib + HP maintenance and BBB‑penetrant ZN‑A‑1041 combinations to proactively address CNS disease.
  • Emerging Themes & Macro-Trends
    • Portfolio strategies are pivoting toward bispecific and non–topo‑I ADCs, BBB‑penetrant HER2 regimens with maintenance designs, and biology‑guided de‑escalation using pCR and nodal‑sparing approaches to reduce treatment burden while preserving outcomes.
FDA Approvals/Withdrawals
FDA Approvals/Withdrawals
  • On May 1, 2026, the FDA approved vepdegestrant (Veppanu, Arvinas Operations, Inc.) for adults with ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer that has progressed after at least one line of endocrine therapy.¹ (read more)
  • On May 15, 2026, the FDA approved fam-trastuzumab deruxtecan-nxki (Enhertu, Daiichi Sankyo, Inc.) for two indications in HER2-positive early-stage breast cancer: neoadjuvant treatment for Stage II or III disease followed by taxane, trastuzumab, and pertuzumab, and for patients with residual invasive disease after neoadjuvant HER2-targeted treatment.² (read more)
  • On May 22, 2026, the FDA approved datopotamab deruxtecan-dlnk (Datroway, Daiichi Sankyo, Inc.) for adult patients with unresectable or metastatic triple-negative breast cancer who are not candidates for PD-1/PD-L1 inhibitor therapy.³ (read more)
Clinical Development Regulatory Updates
Clinical Development Regulatory Updates
  • Arvinas announced FDA approval of Veppanu (vepdegestrant) for adults with ER-positive, HER2-negative, ESR1‑mutated advanced or metastatic breast cancer, noting the decision came ahead of the FDA-assigned PDUFA action date of June 5, 2026. The company reiterated ongoing commercialization transition plans with partners following approval. (ir.arvinas.com) ¹ (read more)
  • FDA approved Enhertu (fam-trastuzumab deruxtecan-nxki) for two early-stage HER2‑positive breast cancer indications (neoadjuvant and adjuvant) and stated the adjuvant application received Priority Review. The agency conducted both reviews under Project Orbis and utilized the Assessment Aid pathway. (fda.gov) ² (read more)
  • Daiichi Sankyo reported U.S. approval of Enhertu for two early breast cancer indications, highlighting the curative-intent settings. The company noted the reviews were conducted under Project Orbis and referenced supporting Phase 3 data from DESTINY‑Breast11 and DESTINY‑Breast05. (daiichisankyo.us) ³ (read more)
  • FDA approved Datroway (datopotamab deruxtecan-dlnk) for unresectable or metastatic triple‑negative breast cancer in patients not eligible for PD‑1/PD‑L1 inhibitor therapy, granting Priority Review. The review was conducted under Project Orbis and used the Assessment Aid. (fda.gov) ⁴ (read more)
  • Daiichi Sankyo announced U.S. approval of Datroway for first‑line metastatic TNBC patients who are not candidates for immunotherapy, stating the approval followed FDA Priority Review. The company also confirmed the application was reviewed under Project Orbis with several participating regulators. (daiichisankyo.us) ⁵ (read more)
  • Celcuity updated that FDA accepted its NDA for gedatolisib in HR+/HER2–/PIK3CA wild‑type advanced breast cancer, granted Priority Review, and assigned a PDUFA goal date of July 17, 2026. The company also disclosed a recent FDA Type B meeting that aligned on amendments to the Phase 3 VIKTORIA‑2 trial design. (ir.celcuity.com) ⁶ (read more)
  • Celcuity’s first‑quarter 2026 update reiterated FDA acceptance of the gedatolisib NDA with Priority Review and the July 17, 2026 PDUFA goal date. Management stated they are preparing for a potential commercial launch in the third quarter of 2026. (ir.celcuity.com) ⁷ (read more)
  • BriaCell received FDA clearance of an Investigational New Drug (IND) application to initiate the Phase 1/2a Bria‑BRES+ clinical study in metastatic breast cancer. The company plans to commence the trial in the coming months. (globenewswire.com) ⁸ (read more)
  • BriaCell reported a positive DSMB recommendation to continue its pivotal Phase 3 study in metastatic breast cancer, noting the program is being conducted under FDA Fast Track designation. The company emphasized the designation reflects the unmet need in this setting. (globenewswire.com) ⁹ (read more)
  • Olema Oncology reported Q1 2026 results and highlighted FDA Fast Track designation for palazestrant (OP‑1250) in ER+/HER2– metastatic breast cancer. The update also reiterated that the IND for OP‑3136 (KAT6 inhibitor) was cleared by FDA, with patients enrolling in the Phase 1 study. (ir.olema.com) ¹⁰ (read more)
  • Olema Oncology presented initial Phase 1 data for OP‑3136 and reiterated that the IND for OP‑3136 had been cleared by FDA, enabling ongoing development in ER+/HER2– advanced breast cancer. Trial-in-progress details for the pivotal OPERA‑02 study of palazestrant plus ribociclib were also shared. (ir.olema.com) ¹¹ (read more)
Conference
Major Conference Updates
Conference Information
  • ASCO 2026 Annual Meeting, Chicago, Illinois, May 29–June 2, 2026; ESMO Breast Cancer 2026 Annual Congress, Berlin, Germany, May 6–8, 2026. (read more)
  • Overall takeaways: momentum toward earlier endocrine strategies, ADC differentiation beyond T-DXd, HER2+ maintenance/CNS-first designs, and biologically guided de-escalation that may reduce treatment burden. (read more)
  • Theme 1: Oral SERDs and Neoadjuvant Endocrine Intensification
    • Significance: Curative-intent settings dominate ER+/HER2– disease; positive phase III SERD signals and neoadjuvant endocrine combinations could reset standards and expand premenopausal options. (read more)
    • Mechanism insights / clinical impact: Giredestrant (oral SERD) showed consistent efficacy across menopausal subgroups in lidERA and activity signals in persevERA/evERA combinations; (Z)-endoxifen plus goserelin (EVANGELINE) targets ER and PKC/AKT biology to drive early antiproliferative responses. (read more)
    • Patient populations affected: ER+/HER2– early breast cancer (adjuvant) and premenopausal cT2–3, cN0–1 neoadjuvant cohorts; global applicability with oral access advantages. (read more)
  • Theme 2: ADC Strategy—Bispecific Innovation vs. Topo‑I Cross‑Resistance
    • Significance: After widespread T-DXd use, next-line benefit depends on overcoming antigen heterogeneity and payload cross-resistance. (read more)
    • Mechanism insights / clinical impact: JSKN016, a first‑in‑class anti‑TROP2/HER3 bispecific ADC (topoisomerase I payload, cleavable linker, DAR4) aims to address heterogeneous HER2‑negative tumors; SATEEN suggests limited efficacy of Trodelvy + Herceptin after Enhertu, implicating shared topo‑I resistance. (read more)
    • Patient populations affected: HER2‑negative metastatic breast cancer (including TNBC) and T‑DXd–experienced HER2+ disease seeking non–cross‑resistant ADC options. (read more)
  • Theme 3: HER2+ Metastatic—Maintenance and CNS‑First Designs
    • Significance: Durable disease control increasingly hinges on proactive CNS management and optimized maintenance post‑induction. (read more)
    • Mechanism insights / clinical impact: Tucatinib + HP as maintenance vs placebo + HP targets ongoing HER2 signaling; ZN‑A‑1041, a BBB‑permeable HER2 TKI, is combined with T‑DXd or pertuzumab‑trastuzumab to address brain metastases risk. (read more)
    • Patient populations affected: HER2+ metastatic patients entering maintenance and those with/at risk for CNS disease, including heavily pretreated cohorts. (read more)
  • Theme 4: Biology‑Guided De‑escalation (Surgery and Systemic)
    • Significance: Reducing morbidity without sacrificing outcomes is a priority; de‑escalation can cut lymphedema, neuropathy, and cost. ([]())
    • Mechanism insights / clinical impact: ASCO data support omitting axillary lymph node dissection in select patients with limited sentinel‑node spread; PHERGain‑2 uses pCR to guide skipping adjuvant chemotherapy with quality‑of‑life gains (recurrence data pending). ([]())
    • Patient populations affected: Early‑stage HER2+ achieving pCR; clinically node‑negative with minimal sentinel‑node involvement in breast‑conserving pathways. ([]())
  • Significance
    • Expected clinical or translational readouts: Full ASCO presentations for giredestrant (lidERA subgroup, persevERA LBA1006) and HER2 CNS‑oriented combinations (ZN‑A‑1041) will refine positioning. (read more)
    • Regulatory or policy implications: Giredestrant submission in early ER+ disease signals a potential first oral SERD entry in the curative setting. (read more)
    • Potential shifts in standard of care: Oral SERDs in adjuvant therapy; maintenance tucatinib strategies; ADC selection avoiding sequential topo‑I payloads; selective omission of ALND/chemo with validated response biomarkers. (ascopubs.org) (read more)
    • Strategic implications: Invest in bispecific ADCs and non–topo‑I payloads; prioritize BBB‑penetrant HER2 regimens; expand neoadjuvant endocrine trials in premenopausal ER+ disease; build diagnostics for pCR‑based and nodal‑sparing pathways. (ascopubs.org) (read more)
Publications Related to Approved Drugs
PHASE2, PHASE3
inavolisib
Safety analyses of the INAVO120 randomised phase III trial of inavolisib or placebo with palbociclib-fulvestrant in patients with PIK3CA-mutated, hormone receptor-positive, HER2-negative, endocrine-resistant advanced breast cancer. This comprehensive analysis demonstrated that the addition of inavolisib to palbociclib and fulvestrant yields a manageable safety profile, with key adverse events like hyperglycemia and stomatitis being generally reversible. These toxicities were effectively controlled through concomitant medications and dose modifications, reinforcing the clinical viability of this targeted combination strategy. ()
Phase 3
ado-trastuzumab emtansine
Cost-effectiveness analysis of the treatment pathway after trastuzumab treatment failure in patients with HER2-positive advanced breast cancer: a chinese health system perspective. This health economics study revealed that pyrotinib plus capecitabine, trastuzumab emtansine (T-DM1), and trastuzumab deruxtecan (T-DXd) were not cost-effective compared to lapatinib plus capecitabine within the Chinese healthcare system. The findings highlight that drug costs and progression-free survival hazard ratios are primary drivers of incremental cost-effectiveness, emphasizing the need for value-based pricing strategies in advanced breast cancer management. ()
New Publications Related to Drugs in Clinical Trial Development
Here are the summaries:
Phase 2
Efficacy and CNS Toxicity of Nivolumab and Ipilimumab in Rare Cancer Brain Metastases: A Multicenter Basket Trial Analysis (NCI/SWOG S1609). Dual immune checkpoint inhibitor therapy with nivolumab and ipilimumab demonstrated comparable systemic efficacy and safety in patients with rare cancers, regardless of the presence of brain metastases. However, no intracranial complete or partial responses were observed, highlighting the need for further research into effective treatments for brain metastases in this population. ()
Phase 3
Fulvestrant versus capecitabine as maintenance therapy in hormone receptor-positive, HER2-negative metastatic breast cancer after first-line chemotherapy (FAMILY): a multicenter, open-label, randomized, phase 3 trial. Fulvestrant maintenance therapy significantly improved progression-free survival compared to capecitabine in patients with HR+/HER2- metastatic breast cancer who achieved disease control after first-line chemotherapy. This finding supports fulvestrant as a more effective and well-tolerated maintenance strategy in this clinical setting. ()
Phase 2
Outcomes After Intratumoral Delivery of Immunotherapy in Breast Cancer. Intratumoral injection of immunotherapy agents, such as talimogene laherparepvec and dendritic cells, is a feasible and safe approach in breast cancer that may minimize systemic toxicity while maintaining therapeutic efficacy. This localized delivery method represents a promising strategy for managing challenging breast cancer subtypes. ()
Phase 3
Perceptions and lived experiences with abemaciclib and endocrine therapy for early breast cancer: a rapid communication. Initial patient experiences with adjuvant abemaciclib plus endocrine therapy for high-risk early breast cancer indicate that while early-onset diarrhea is common and bothersome, it is generally manageable with supportive care and dietary modifications. Regular follow-up and proactive symptom management are crucial to support treatment adherence and optimize patient outcomes. ()
Phase 2
Carboplatin with or without nivolumab in metastatic triple-negative breast cancer: a randomized phase II trial. The addition of nivolumab to carboplatin did not significantly improve progression-free survival in the overall population of patients with metastatic triple-negative breast cancer. However, a trend toward improved outcomes was observed in the PD-L1-positive subgroup, suggesting a potential role for this combination in selected patients. ()
Phase 3
Bireociclib Plus Fulvestrant in Advanced Breast Cancer After Endocrine Progression: The BRIGHT-2 Phase 3 Randomized Clinical Trial. The addition of bireociclib to fulvestrant significantly prolonged progression-free survival compared to placebo plus fulvestrant in patients with HR-positive, HER2-negative advanced breast cancer who progressed on prior endocrine therapy. This combination offers a new, effective treatment option with a manageable safety profile for this patient population. ()
Phase 2
Trastuzumab deruxtecan in HER2-expressing gynecologic cancers from DESTINY-PanTumor02: antitumor activity, safety, and exploratory biomarker analyses. Trastuzumab deruxtecan demonstrated clinically meaningful objective response rates across HER2-expressing endometrial, cervical, and ovarian cancers, with the highest responses seen in HER2 IHC 3+ tumors. These findings support the use of this antibody-drug conjugate as a therapeutic option for pretreated HER2-expressing gynecologic malignancies. ()
Phase 3
Cost-effectiveness analysis of the treatment pathway after trastuzumab treatment failure in patients with HER2-positive advanced breast cancer: a chinese health system perspective. In the Chinese healthcare system, alternative regimens such as pyrotinib plus capecitabine, T-DM1, and T-DXd were not found to be cost-effective compared to lapatinib plus capecitabine for HER2-positive advanced breast cancer following trastuzumab failure. This highlights the economic challenges of integrating newer targeted therapies into standard care pathways. ()
Phase 1
Outcomes After Intratumoral Delivery of Immunotherapy in Breast Cancer. Intratumoral injection of immunotherapy agents, such as talimogene laherparepvec and dendritic cells, is a feasible and safe approach in breast cancer that may minimize systemic toxicity while maintaining therapeutic efficacy. This localized delivery method represents a promising strategy for managing challenging breast cancer subtypes. ()
Phase 3
Healthcare Systems Data (HSD) to Improve the Efficiency of Clinical Trials Within the UK: A Prospectively Planned Comparison of HSD and Trial-Reported Outcomes Within the Add-Aspirin Cancer Clinical Trial. While healthcare systems data showed good concordance for initial cancer staging, it was insufficient to replace trial-specific case-report forms for long-term follow-up due to incomplete capture of recurrences and specific adverse events. Selective use of this data retains potential for improving trial efficiency, but hospital-based follow-up remains necessary for accurate outcome assessment. ()
N/A
The ARTEMIS trial identifies immune activation as a key predictor of neoadjuvant chemotherapy response in triple-negative breast cancer. The ARTEMIS trial revealed that the immune contexture, specifically the presence of an "immune hot" tumor microenvironment, is a critical predictor of response to neoadjuvant doxorubicin and cyclophosphamide in early-stage triple-negative breast cancer. This finding provides a framework for personalizing therapy and potentially de-escalating treatment in patients with immune-sensitive tumors. ()
Phase 1
B7-H3 (CD276) as Target for T Cell-Based Bispecific Antibody Therapy of Penile Cancer. The B7-H3xCD3 bispecific antibody CC-3 demonstrated potent T cell activation and tumor cell lysis in preclinical models of penile cancer, validating B7-H3 as a relevant target for immunotherapy in this rare malignancy. These results support the ongoing clinical evaluation of CC-3 in patients with advanced penile cancer. ()
Phase 2
Outcomes After Intratumoral Delivery of Immunotherapy in Breast Cancer. Intratumoral injection of immunotherapy agents, such as talimogene laherparepvec and dendritic cells, is a feasible and safe approach in breast cancer that may minimize systemic toxicity while maintaining therapeutic efficacy. This localized delivery method represents a promising strategy for managing challenging breast cancer subtypes. ()
Phase 2
Longitudinal DCE MRI Vascular Textures: Radiologic and Biologic Insights for pCR Prediction in HER2-Negative Breast Cancer. Incorporating dynamic contrast-enhanced MRI vascular texture dynamics at midtreatment significantly improved the prediction of pathologic complete response in HER2-negative breast cancer compared to clinical and functional tumor volume features alone. This imaging biomarker approach offers a non-invasive method to assess early treatment response and guide therapeutic decisions. ()
PHASE1, PHASE2
Immuno-PET/CT Imaging of Trop2 Expression with [18F]AlF-RESCA-RT4 Enhances Diagnosis of Breast Cancers and the Metastases. The novel Trop2-targeted tracer [18F]AlF-RESCA-RT4 demonstrated high sensitivity and specificity for detecting primary breast tumors and metastases, outperforming 18F-FDG PET/CT in identifying nodal and bone lesions. This immuno-PET/CT imaging approach offers a superior diagnostic tool for evaluating Trop2-positive breast cancer. ()
Phase 1
Safety and antitumour activity of ipatasertib combined with endocrine therapy and a CDK4/6 inhibitor in HR+/HER2- metastatic breast cancer (TAKTIC): a single-centre, open-label, phase 1b trial. The combination of the AKT inhibitor ipatasertib, fulvestrant, and palbociclib showed preliminary clinical activity and a manageable safety profile in heavily pretreated patients with HR+/HER2- metastatic breast cancer. This strategy warrants further investigation as a potential treatment option for patients with CDK4/6 inhibitor-refractory disease. ()
Phase 2
Enfortumab vedotin plus pembrolizumab as first-line treatment in recurrent or metastatic head and neck squamous cell carcinoma: results from EV-202 cohort 9. The combination of enfortumab vedotin and pembrolizumab demonstrated promising clinical activity and a manageable safety profile as a first-line treatment for patients with PD-L1 positive recurrent or metastatic head and neck squamous cell carcinoma. These findings support further evaluation of this combination in this patient population. ()
Phase 3
Datopotamab deruxtecan versus chemotherapy in previously treated inoperable/metastatic hormone receptor-positive, HER2-negative breast cancer: final overall survival analysis of the phase III TROPION-Breast01 study. While datopotamab deruxtecan significantly improved progression-free survival compared to chemotherapy in previously treated HR+/HER2- metastatic breast cancer, the final overall survival analysis did not reach statistical significance, potentially due to the use of subsequent antibody-drug conjugate therapies. Nevertheless, the favorable efficacy and safety profile supports datopotamab deruxtecan as a new treatment option in this setting. ()
Phase 2
Randomised, multicentre phase II study of bevacizumab and paclitaxel induction followed by atezolizumab and nab-paclitaxel in patients with PD-L1-positive metastatic triple-negative breast cancer: protocol for the INDUCE trial (JBCRG-M10). The INDUCE trial is investigating whether induction therapy with bevacizumab and paclitaxel can enhance the immune-mediated antitumor efficacy of subsequent atezolizumab and nab-paclitaxel in patients with PD-L1-positive metastatic triple-negative breast cancer. This novel sequential approach aims to overcome resistance mechanisms and improve progression-free survival in this challenging disease subtype. ()
PHASE1, PHASE2
Durvalumab Plus Paclitaxel, with or without Capivasertib or Oleclumab, in Patients with Locally Advanced/Metastatic Triple-Negative Breast Cancer. The combination of durvalumab and paclitaxel demonstrated clinical activity and tolerability in patients with locally advanced or metastatic triple-negative breast cancer, with enhanced responses observed in PD-L1-positive tumors. However, the addition of capivasertib or oleclumab to this regimen did not provide substantial additional benefit. ()
PHASE1, PHASE2
Datopotamab deruxtecan (Dato-DXd) in combination with durvalumab as first-line treatment for unresectable locally advanced or metastatic triple-negative breast cancer: results from arms 7 and 8 of the phase Ib/II BEGONIA study. First-line treatment with datopotamab deruxtecan plus durvalumab demonstrated substantial and durable antitumor activity in patients with locally advanced or metastatic triple-negative breast cancer, regardless of PD-L1 status. This combination showed a manageable safety profile, supporting its potential as a highly effective therapeutic strategy in this setting. ()
Phase 2
Elraglusib and chemotherapy in metastatic pancreatic ductal adenocarcinoma: a randomized controlled phase 2 trial. The addition of the GSK-3β inhibitor elraglusib to gemcitabine and nab-paclitaxel significantly improved overall survival and 1-year survival rates compared to chemotherapy alone in patients with previously untreated metastatic pancreatic ductal adenocarcinoma. These findings, along with a manageable safety profile, support the advancement of this combination into phase 3 clinical trials. ()
Phase 3
Nine-Year Recurrence-Free Survival in Gastric Signet-Ring Cell Carcinoma: A Case Report of Laparoscopic Radical Resection Combining Long-Term Systematic Therapy and Metformin Enteric-Coated Tablets. A patient with aggressive gastric signet-ring cell carcinoma achieved a remarkable 9-year recurrence-free survival following laparoscopic radical resection and a long-term adjuvant regimen that included metformin. This case highlights the potential of individualized, multi-modality therapy to improve outcomes in this poor-prognosis malignancy. ()
PHASE1, PHASE2
Outcomes After Intratumoral Delivery of Immunotherapy in Breast Cancer. Intratumoral injection of immunotherapy agents, such as talimogene laherparepvec and dendritic cells, is a feasible and safe approach in breast cancer that may minimize systemic toxicity while maintaining therapeutic efficacy. This localized delivery method represents a promising strategy for managing challenging breast cancer subtypes. ()
Phase 1
Safety and immunogenicity of a tri-antigen vaccine targeting IGFBP-2, HER2, and IGF-IR in participants with non-metastatic breast cancer. A novel tri-antigen plasmid-DNA vaccine targeting IGFBP-2, HER2, and IGF-IR demonstrated safety and significant immunogenicity in patients with non-metastatic breast cancer, with the 300 µg dose inducing long-term persistence of immunity. These promising results support the advancement of this vaccine into phase II trials for the treatment of ductal carcinoma in situ. ()
Phase 2
Survival Analysis of the WSG TP-II Trial: Neoadjuvant Trastuzumab and Pertuzumab Plus Endocrine Therapy Versus Chemotherapy in Hormone Receptor-Positive/Human Epidermal Growth Factor Receptor 2-Positive Early Breast Cancer. The 5-year survival analysis of the WSG TP-II trial confirms that a de-escalated neoadjuvant approach using dual HER2 blockade combined with either endocrine therapy or paclitaxel yields excellent survival outcomes in patients with HR+/HER2+ early breast cancer. This supports the safety and efficacy of pCR-guided adjuvant therapy strategies to minimize toxicity in this patient population. ()
Phase 3
The fixed-dose combination of pertuzumab and trastuzumab for subcutaneous injection in Chinese patients with HER2-positive early breast cancer: primary analysis of the phase III, randomized FDChina study. The subcutaneous fixed-dose combination of pertuzumab and trastuzumab demonstrated non-inferior pharmacokinetics and comparable pathological complete response rates and safety to the intravenous formulation in Chinese patients with HER2-positive early breast cancer. This provides a more convenient and viable treatment option for this patient population. ()
Early Phase 1
Outcomes After Intratumoral Delivery of Immunotherapy in Breast Cancer. Intratumoral injection of immunotherapy agents, such as talimogene laherparepvec and dendritic cells, is a feasible and safe approach in breast cancer that may minimize systemic toxicity while maintaining therapeutic efficacy. This localized delivery method represents a promising strategy for managing challenging breast cancer subtypes. ()
PHASE1, PHASE2
The multi-kinase inhibitor tinengotinib as monotherapy or combined with atezolizumab in advanced solid tumors: a phase Ib/II trial. Tinengotinib, a spectrum-selective multi-kinase inhibitor, demonstrated a favorable safety profile and promising antitumor activity both as a monotherapy and in combination with atezolizumab in patients with advanced solid tumors, particularly cholangiocarcinoma. These findings support the continued clinical development of tinengotinib in these settings. ()
Phase 1
Lipid Nanoparticle-encapsulated mRNA-2752 Encoding Human OX40L, IL-23, and IL-36γ Plus Durvalumab Induces an Immunostimulatory Effect Within the Tumor Microenvironment in Patients with Advanced Solid Tumors. Intratumoral administration of mRNA-2752, alone or in combination with durvalumab, demonstrated manageable safety and promising antitumor activity, particularly in patients with checkpoint inhibitor-resistant melanoma. Biomarker analyses confirmed a sustained inflammatory response within the tumor microenvironment, supporting the potential of mRNA-based therapeutics in advanced cancer. ()
Phase 3
Outcomes of Hormone receptor-positive/HER2-negative early breast cancer patients by risk of recurrence groups focusing on the intermediate-risk group: Retrospective analysis from GEICAM studies. A retrospective analysis of early breast cancer patients revealed that those with intermediate-risk disease experience a steady increase in relapse rates over time, highlighting the need for long-term follow-up to determine the true benefit of adjuvant therapies like ribociclib. These real-world data are crucial for guiding treatment decisions and optimizing endocrine therapy strategies in this patient population. ()
N/A
Feasibility of the Xemio app for breast cancer survivors in a clinical setting: Adherence, acceptance, and side effect monitoring (CTCAE vs. QoL). The Xemio-Research mHealth app demonstrated high initial adherence and excellent usability among breast cancer survivors, enabling more detailed symptom tracking compared to traditional quality-of-life questionnaires. While long-term engagement remains a challenge, integrating such digital tools into clinical practice could enhance personalized care and side effect management. ()
Phase 1
Discovery of Dual A2A/A2B Adenosine Receptor Antagonist and Clinical Candidate INCB106385. The novel dual A2A/A2B adenosine receptor antagonist INCB106385 demonstrated high potency, favorable pharmacokinetics, and significant preclinical efficacy in overcoming adenosine-mediated immune suppression in the tumor microenvironment. These promising characteristics supported its advancement into Phase 1 clinical trials for cancer immunotherapy. ()
Phase 3
Outcomes of Hormone receptor-positive/HER2-negative early breast cancer patients by risk of recurrence groups focusing on the intermediate-risk group: Retrospective analysis from GEICAM studies. A retrospective analysis of early breast cancer patients revealed that those with intermediate-risk disease experience a steady increase in relapse rates over time, highlighting the need for long-term follow-up to determine the true benefit of adjuvant therapies like ribociclib. These real-world data are crucial for guiding treatment decisions and optimizing endocrine therapy strategies in this patient population. ()
Phase 3
Outcomes of Hormone receptor-positive/HER2-negative early breast cancer patients by risk of recurrence groups focusing on the intermediate-risk group: Retrospective analysis from GEICAM studies. A retrospective analysis of early breast cancer patients revealed that those with intermediate-risk disease experience a steady increase in relapse rates over time, highlighting the need for long-term follow-up to determine the true benefit of adjuvant therapies like ribociclib. These real-world data are crucial for guiding treatment decisions and optimizing endocrine therapy strategies in this patient population. ()
Phase 3
Sensitivity to endocrine therapy index predicts benefit from weekly adjuvant paclitaxel for hormone receptor-positive breast cancer in the GEICAM/9906 trial. The SETER/PR index successfully identified a subset of patients with HR+/HER2- breast cancer and low endocrine transcriptional activity who significantly benefited from the addition of weekly paclitaxel to adjuvant chemotherapy. This validates the SETER/PR index as a predictive biomarker to guide the selection of paclitaxel-based regimens in this patient population. ()
Phase 3
Outcomes of Hormone receptor-positive/HER2-negative early breast cancer patients by risk of recurrence groups focusing on the intermediate-risk group: Retrospective analysis from GEICAM studies. A retrospective analysis of early breast cancer patients revealed that those with intermediate-risk disease experience a steady increase in relapse rates over time, highlighting the need for long-term follow-up to determine the true benefit of adjuvant therapies like ribociclib. These real-world data are crucial for guiding treatment decisions and optimizing endocrine therapy strategies in this patient population. ()
Phase 3
DXA-Derived Abdominal Adiposity and Obesity-Related Cancer Risk Among Postmenopausal Women in the Women's Health Initiative. Higher visceral abdominal adiposity, as measured by DXA scans, was strongly and independently associated with an increased risk of obesity-related cancers in postmenopausal women. Incorporating imaging-based body composition measures could improve cancer risk stratification and inform targeted prevention strategies. ()
Early Phase 1
Preoperative onapristone-XR in postmenopausal women with progesterone receptor-positive (PgR+)/HER2-negative early breast cancer: SOLTI-1802 ONAWA trial results. Preoperative treatment with the antiprogestin onapristone-XR significantly suppressed tumor proliferation, particularly in tumors with high baseline progesterone receptor expression, in postmenopausal women with early breast cancer. These findings support the potential of onapristone-XR as a targeted therapeutic strategy and warrant further clinical evaluation. () I will now format the final answer.
Phase 2
Efficacy and CNS Toxicity of Nivolumab and Ipilimumab in Rare Cancer Brain Metastases: A Multicenter Basket Trial Analysis (NCI/SWOG S1609). Dual immune checkpoint inhibitor therapy with nivolumab and ipilimumab demonstrated comparable systemic efficacy and safety in patients with rare cancers, regardless of the presence of brain metastases. However, no intracranial complete or partial responses were observed, highlighting the need for further research into effective treatments for brain metastases in this population. ()
Phase 3
Fulvestrant versus capecitabine as maintenance therapy in hormone receptor-positive, HER2-negative metastatic breast cancer after first-line chemotherapy (FAMILY): a multicenter, open-label, randomized, phase 3 trial. Fulvestrant maintenance therapy significantly improved progression-free survival compared to capecitabine in patients with HR+/HER2- metastatic breast cancer who achieved disease control after first-line chemotherapy. This finding supports fulvestrant as a more effective and well-tolerated maintenance strategy in this clinical setting. ()
Phase 2
Outcomes After Intratumoral Delivery of Immunotherapy in Breast Cancer. Intratumoral injection of immunotherapy agents, such as talimogene laherparepvec and dendritic cells, is a feasible and safe approach in breast cancer that may minimize systemic toxicity while maintaining therapeutic efficacy. This localized delivery method represents a promising strategy for managing challenging breast cancer subtypes. ()
Phase 3
Perceptions and lived experiences with abemaciclib and endocrine therapy for early breast cancer: a rapid communication. Initial patient experiences with adjuvant abemaciclib plus endocrine therapy for high-risk early breast cancer indicate that while early-onset diarrhea is common and bothersome, it is generally manageable with supportive care and dietary modifications. Regular follow-up and proactive symptom management are crucial to support treatment adherence and optimize patient outcomes. ()
Phase 2
Carboplatin with or without nivolumab in metastatic triple-negative breast cancer: a randomized phase II trial. The addition of nivolumab to carboplatin did not significantly improve progression-free survival in the overall population of patients with metastatic triple-negative breast cancer. However, a trend toward improved outcomes was observed in the PD-L1-positive subgroup, suggesting a potential role for this combination in selected patients. ()
Phase 3
Bireociclib Plus Fulvestrant in Advanced Breast Cancer After Endocrine Progression: The BRIGHT-2 Phase 3 Randomized Clinical Trial. The addition of bireociclib to fulvestrant significantly prolonged progression-free survival compared to placebo plus fulvestrant in patients with HR-positive, HER2-negative advanced breast cancer who progressed on prior endocrine therapy. This combination offers a new, effective treatment option with a manageable safety profile for this patient population. ()
Phase 2
Trastuzumab deruxtecan in HER2-expressing gynecologic cancers from DESTINY-PanTumor02: antitumor activity, safety, and exploratory biomarker analyses. Trastuzumab deruxtecan demonstrated clinically meaningful objective response rates across HER2-expressing endometrial, cervical, and ovarian cancers, with the highest responses seen in HER2 IHC 3+ tumors. These findings support the use of this antibody-drug conjugate as a therapeutic option for pretreated HER2-expressing gynecologic malignancies. ()
Phase 3
Cost-effectiveness analysis of the treatment pathway after trastuzumab treatment failure in patients with HER2-positive advanced breast cancer: a chinese health system perspective. In the Chinese healthcare system, alternative regimens such as pyrotinib plus capecitabine, T-DM1, and T-DXd were not found to be cost-effective compared to lapatinib plus capecitabine for HER2-positive advanced breast cancer following trastuzumab failure. This highlights the economic challenges of integrating newer targeted therapies into standard care pathways. ()
Phase 1
Outcomes After Intratumoral Delivery of Immunotherapy in Breast Cancer. Intratumoral injection of immunotherapy agents, such as talimogene laherparepvec and dendritic cells, is a feasible and safe approach in breast cancer that may minimize systemic toxicity while maintaining therapeutic efficacy. This localized delivery method represents a promising strategy for managing challenging breast cancer subtypes. ()
Phase 3
Healthcare Systems Data (HSD) to Improve the Efficiency of Clinical Trials Within the UK: A Prospectively Planned Comparison of HSD and Trial-Reported Outcomes Within the Add-Aspirin Cancer Clinical Trial. While healthcare systems data showed good concordance for initial cancer staging, it was insufficient to replace trial-specific case-report forms for long-term follow-up due to incomplete capture of recurrences and specific adverse events. Selective use of this data retains potential for improving trial efficiency, but hospital-based follow-up remains necessary for accurate outcome assessment. ()
N/A
The ARTEMIS trial identifies immune activation as a key predictor of neoadjuvant chemotherapy response in triple-negative breast cancer. The ARTEMIS trial revealed that the immune contexture, specifically the presence of an "immune hot" tumor microenvironment, is a critical predictor of response to neoadjuvant doxorubicin and cyclophosphamide in early-stage triple-negative breast cancer. This finding provides a framework for personalizing therapy and potentially de-escalating treatment in patients with immune-sensitive tumors. ()
Phase 1
B7-H3 (CD276) as Target for T Cell-Based Bispecific Antibody Therapy of Penile Cancer. The B7-H3xCD3 bispecific antibody CC-3 demonstrated potent T cell activation and tumor cell lysis in preclinical models of penile cancer, validating B7-H3 as a relevant target for immunotherapy in this rare malignancy. These results support the ongoing clinical evaluation of CC-3 in patients with advanced penile cancer. ()
Phase 2
Outcomes After Intratumoral Delivery of Immunotherapy in Breast Cancer. Intratumoral injection of immunotherapy agents, such as talimogene laherparepvec and dendritic cells, is a feasible and safe approach in breast cancer that may minimize systemic toxicity while maintaining therapeutic efficacy. This localized delivery method represents a promising strategy for managing challenging breast cancer subtypes. ()
Phase 2
Longitudinal DCE MRI Vascular Textures: Radiologic and Biologic Insights for pCR Prediction in HER2-Negative Breast Cancer. Incorporating dynamic contrast-enhanced MRI vascular texture dynamics at midtreatment significantly improved the prediction of pathologic complete response in HER2-negative breast cancer compared to clinical and functional tumor volume features alone. This imaging biomarker approach offers a non-invasive method to assess early treatment response and guide therapeutic decisions. ()
PHASE1, PHASE2
Immuno-PET/CT Imaging of Trop2 Expression with [18F]AlF-RESCA-RT4 Enhances Diagnosis of Breast Cancers and the Metastases. The novel Trop2-targeted tracer [18F]AlF-RESCA-RT4 demonstrated high sensitivity and specificity for detecting primary breast tumors and metastases, outperforming 18F-FDG PET/CT in identifying nodal and bone lesions. This immuno-PET/CT imaging approach offers a superior diagnostic tool for evaluating Trop2-positive breast cancer. ()
Phase 1
Safety and antitumour activity of ipatasertib combined with endocrine therapy and a CDK4/6 inhibitor in HR+/HER2- metastatic breast cancer (TAKTIC): a single-centre, open-label, phase 1b trial. The combination of the AKT inhibitor ipatasertib, fulvestrant, and palbociclib showed preliminary clinical activity and a manageable safety profile in heavily pretreated patients with HR+/HER2- metastatic breast cancer. This strategy warrants further investigation as a potential treatment option for patients with CDK4/6 inhibitor-refractory disease. ()
Phase 2
Enfortumab vedotin plus pembrolizumab as first-line treatment in recurrent or metastatic head and neck squamous cell carcinoma: results from EV-202 cohort 9. The combination of enfortumab vedotin and pembrolizumab demonstrated promising clinical activity and a manageable safety profile as a first-line treatment for patients with PD-L1 positive recurrent or metastatic head and neck squamous cell carcinoma. These findings support further evaluation of this combination in this patient population. ()
Phase 3
Datopotamab deruxtecan versus chemotherapy in previously treated inoperable/metastatic hormone receptor-positive, HER2-negative breast cancer: final overall survival analysis of the phase III TROPION-Breast01 study. While datopotamab deruxtecan significantly improved progression-free survival compared to chemotherapy in previously treated HR+/HER2- metastatic breast cancer, the final overall survival analysis did not reach statistical significance, potentially due to the use of subsequent antibody-drug conjugate therapies. Nevertheless, the favorable efficacy and safety profile supports datopotamab deruxtecan as a new treatment option in this setting. ()
Phase 2
Randomised, multicentre phase II study of bevacizumab and paclitaxel induction followed by atezolizumab and nab-paclitaxel in patients with PD-L1-positive metastatic triple-negative breast cancer: protocol for the INDUCE trial (JBCRG-M10). The INDUCE trial is investigating whether induction therapy with bevacizumab and paclitaxel can enhance the immune-mediated antitumor efficacy of subsequent atezolizumab and nab-paclitaxel in patients with PD-L1-positive metastatic triple-negative breast cancer. This novel sequential approach aims to overcome resistance mechanisms and improve progression-free survival in this challenging disease subtype. ()
PHASE1, PHASE2
Durvalumab Plus Paclitaxel, with or without Capivasertib or Oleclumab, in Patients with Locally Advanced/Metastatic Triple-Negative Breast Cancer. The combination of durvalumab and paclitaxel demonstrated clinical activity and tolerability in patients with locally advanced or metastatic triple-negative breast cancer, with enhanced responses observed in PD-L1-positive tumors. However, the addition of capivasertib or oleclumab to this regimen did not provide substantial additional benefit. ()
PHASE1, PHASE2
Datopotamab deruxtecan (Dato-DXd) in combination with durvalumab as first-line treatment for unresectable locally advanced or metastatic triple-negative breast cancer: results from arms 7 and 8 of the phase Ib/II BEGONIA study. First-line treatment with datopotamab deruxtecan plus durvalumab demonstrated substantial and durable antitumor activity in patients with locally advanced or metastatic triple-negative breast cancer, regardless of PD-L1 status. This combination showed a manageable safety profile, supporting its potential as a highly effective therapeutic strategy in this setting. ()
Phase 2
Elraglusib and chemotherapy in metastatic pancreatic ductal adenocarcinoma: a randomized controlled phase 2 trial. The addition of the GSK-3β inhibitor elraglusib to gemcitabine and nab-paclitaxel significantly improved overall survival and 1-year survival rates compared to chemotherapy alone in patients with previously untreated metastatic pancreatic ductal adenocarcinoma. These findings, along with a manageable safety profile, support the advancement of this combination into phase 3 clinical trials. ()
Phase 3
Nine-Year Recurrence-Free Survival in Gastric Signet-Ring Cell Carcinoma: A Case Report of Laparoscopic Radical Resection Combining Long-Term Systematic Therapy and Metformin Enteric-Coated Tablets. A patient with aggressive gastric signet-ring cell carcinoma achieved a remarkable 9-year recurrence-free survival following laparoscopic radical resection and a long-term adjuvant regimen that included metformin. This case highlights the potential of individualized, multi-modality therapy to improve outcomes in this poor-prognosis malignancy. ()
PHASE1, PHASE2
Outcomes After Intratumoral Delivery of Immunotherapy in Breast Cancer. Intratumoral injection of immunotherapy agents, such as talimogene laherparepvec and dendritic cells, is a feasible and safe approach in breast cancer that may minimize systemic toxicity while maintaining therapeutic efficacy. This localized delivery method represents a promising strategy for managing challenging breast cancer subtypes. ()
Phase 1
Safety and immunogenicity of a tri-antigen vaccine targeting IGFBP-2, HER2, and IGF-IR in participants with non-metastatic breast cancer. A novel tri-antigen plasmid-DNA vaccine targeting IGFBP-2, HER2, and IGF-IR demonstrated safety and significant immunogenicity in patients with non-metastatic breast cancer, with the 300 µg dose inducing long-term persistence of immunity. These promising results support the advancement of this vaccine into phase II trials for the treatment of ductal carcinoma in situ. ()
Phase 2
Survival Analysis of the WSG TP-II Trial: Neoadjuvant Trastuzumab and Pertuzumab Plus Endocrine Therapy Versus Chemotherapy in Hormone Receptor-Positive/Human Epidermal Growth Factor Receptor 2-Positive Early Breast Cancer. The 5-year survival analysis of the WSG TP-II trial confirms that a de-escalated neoadjuvant approach using dual HER2 blockade combined with either endocrine therapy or paclitaxel yields excellent survival outcomes in patients with HR+/HER2+ early breast cancer. This supports the safety and efficacy of pCR-guided adjuvant therapy strategies to minimize toxicity in this patient population. ()
Phase 3
The fixed-dose combination of pertuzumab and trastuzumab for subcutaneous injection in Chinese patients with HER2-positive early breast cancer: primary analysis of the phase III, randomized FDChina study. The subcutaneous fixed-dose combination of pertuzumab and trastuzumab demonstrated non-inferior pharmacokinetics and comparable pathological complete response rates and safety to the intravenous formulation in Chinese patients with HER2-positive early breast cancer. This provides a more convenient and viable treatment option for this patient population. ()
Early Phase 1
Outcomes After Intratumoral Delivery of Immunotherapy in Breast Cancer. Intratumoral injection of immunotherapy agents, such as talimogene laherparepvec and dendritic cells, is a feasible and safe approach in breast cancer that may minimize systemic toxicity while maintaining therapeutic efficacy. This localized delivery method represents a promising strategy for managing challenging breast cancer subtypes. ()
PHASE1, PHASE2
The multi-kinase inhibitor tinengotinib as monotherapy or combined with atezolizumab in advanced solid tumors: a phase Ib/II trial. Tinengotinib, a spectrum-selective multi-kinase inhibitor, demonstrated a favorable safety profile and promising antitumor activity both as a monotherapy and in combination with atezolizumab in patients with advanced solid tumors, particularly cholangiocarcinoma. These findings support the continued clinical development of tinengotinib in these settings. ()
Phase 1
Lipid Nanoparticle-encapsulated mRNA-2752 Encoding Human OX40L, IL-23, and IL-36γ Plus Durvalumab Induces an Immunostimulatory Effect Within the Tumor Microenvironment in Patients with Advanced Solid Tumors. Intratumoral administration of mRNA-2752, alone or in combination with durvalumab, demonstrated manageable safety and promising antitumor activity, particularly in patients with checkpoint inhibitor-resistant melanoma. Biomarker analyses confirmed a sustained inflammatory response within the tumor microenvironment, supporting the potential of mRNA-based therapeutics in advanced cancer. ()
Phase 3
Outcomes of Hormone receptor-positive/HER2-negative early breast cancer patients by risk of recurrence groups focusing on the intermediate-risk group: Retrospective analysis from GEICAM studies. A retrospective analysis of early breast cancer patients revealed that those with intermediate-risk disease experience a steady increase in relapse rates over time, highlighting the need for long-term follow-up to determine the true benefit of adjuvant therapies like ribociclib. These real-world data are crucial for guiding treatment decisions and optimizing endocrine therapy strategies in this patient population. ()
N/A
Feasibility of the Xemio app for breast cancer survivors in a clinical setting: Adherence, acceptance, and side effect monitoring (CTCAE vs. QoL). The Xemio-Research mHealth app demonstrated high initial adherence and excellent usability among breast cancer survivors, enabling more detailed symptom tracking compared to traditional quality-of-life questionnaires. While long-term engagement remains a challenge, integrating such digital tools into clinical practice could enhance personalized care and side effect management. ()
Phase 1
Discovery of Dual A2A/A2B Adenosine Receptor Antagonist and Clinical Candidate INCB106385. The novel dual A2A/A2B adenosine receptor antagonist INCB106385 demonstrated high potency, favorable pharmacokinetics, and significant preclinical efficacy in overcoming adenosine-mediated immune suppression in the tumor microenvironment. These promising characteristics supported its advancement into Phase 1 clinical trials for cancer immunotherapy. ()
Phase 3
Outcomes of Hormone receptor-positive/HER2-negative early breast cancer patients by risk of recurrence groups focusing on the intermediate-risk group: Retrospective analysis from GEICAM studies. A retrospective analysis of early breast cancer patients revealed that those with intermediate-risk disease experience a steady increase in relapse rates over time, highlighting the need for long-term follow-up to determine the true benefit of adjuvant therapies like ribociclib. These real-world data are crucial for guiding treatment decisions and optimizing endocrine therapy strategies in this patient population. ()
Phase 3
Outcomes of Hormone receptor-positive/HER2-negative early breast cancer patients by risk of recurrence groups focusing on the intermediate-risk group: Retrospective analysis from GEICAM studies. A retrospective analysis of early breast cancer patients revealed that those with intermediate-risk disease experience a steady increase in relapse rates over time, highlighting the need for long-term follow-up to determine the true benefit of adjuvant therapies like ribociclib. These real-world data are crucial for guiding treatment decisions and optimizing endocrine therapy strategies in this patient population. ()
Phase 3
Sensitivity to endocrine therapy index predicts benefit from weekly adjuvant paclitaxel for hormone receptor-positive breast cancer in the GEICAM/9906 trial. The SETER/PR index successfully identified a subset of patients with HR+/HER2- breast cancer and low endocrine transcriptional activity who significantly benefited from the addition of weekly paclitaxel to adjuvant chemotherapy. This validates the SETER/PR index as a predictive biomarker to guide the selection of paclitaxel-based regimens in this patient population. ()
Phase 3
Outcomes of Hormone receptor-positive/HER2-negative early breast cancer patients by risk of recurrence groups focusing on the intermediate-risk group: Retrospective analysis from GEICAM studies. A retrospective analysis of early breast cancer patients revealed that those with intermediate-risk disease experience a steady increase in relapse rates over time, highlighting the need for long-term follow-up to determine the true benefit of adjuvant therapies like ribociclib. These real-world data are crucial for guiding treatment decisions and optimizing endocrine therapy strategies in this patient population. ()
Phase 3
DXA-Derived Abdominal Adiposity and Obesity-Related Cancer Risk Among Postmenopausal Women in the Women's Health Initiative. Higher visceral abdominal adiposity, as measured by DXA scans, was strongly and independently associated with an increased risk of obesity-related cancers in postmenopausal women. Incorporating imaging-based body composition measures could improve cancer risk stratification and inform targeted prevention strategies. ()
Early Phase 1
Preoperative onapristone-XR in postmenopausal women with progesterone receptor-positive (PgR+)/HER2-negative early breast cancer: SOLTI-1802 ONAWA trial results. Preoperative treatment with the antiprogestin onapristone-XR significantly suppressed tumor proliferation, particularly in tumors with high baseline progesterone receptor expression, in postmenopausal women with early breast cancer. These findings support the potential of onapristone-XR as a targeted therapeutic strategy and warrant further clinical evaluation. ()
Clinical Trials
Clinical Trials Summary
Number of Clinical Trials in breast cancer updated from 2026-05-01 to 2026-05-31:
Phase 1Phase 1/2Phase 2Phase 2/3Phase 3Phase 4Total
Enrolling by Invitation1--1--2
Not Yet Recruiting7414-4433
Recruiting2728662282153
Available-------
Approved for Marketing-------
Active, Not Recruiting181139120190
Completed224--19
Total55451234528287
Phase 1 Clinical Trials within 3 Months of Primary Completion Date:
DRUGNCTIDStatusClinical Trial NameCompletion Date
Dalpiciclib, Chidamide NCT05586841 COMPLETED Exploration of Dalpiciclib + Chidamide in HR+/HER2- Advanced Breast Cancer After Failure of CDK4/6 Inhibitor: a Phase Ⅰb Study 2026-03-30
SRG-514 NCT06300411 COMPLETED A Phase 1 Study of SRG-514 Administered Intraoperatively to the Site of Tumor Resection of Patients Undergoing Breast-Conserving Cancer Surgery 2026-04-08
HRS-6209 Capsule (new formulation), HRS-6209 Capsule (old formulation) NCT07610148 NOT_YET_RECRUITING A Single-Center, Single-Dose, Randomized, Open-Label, Three-Period, Three-Sequence, Crossover Study to Evaluate the Oral Relative Bioavailability of Old and New Formulations of HRS-6209 Capsules and the Effect of Food in Healthy Chinese Participants 2026-06
Abemaciclib, BET Bromodomain Inhibitor ZEN-3694 NCT05372640 RECRUITING A Phase 1 Study of BET Bromodomain Inhibitor ZEN003694 in Combination With the CDK4/6 Inhibitor Abemaciclib in Patients With NUT Carcinoma, Breast Cancer and Other Solid Tumors 2026-06-01
Administation of ceralasertib in combination with durvalumab, Administration of ceralasertib and durvalumab, Administration of ceralasertib monotherapy, Administration of ceralasertib in combination with AZD5305, Administration of ceralasertib in combination with carboplatin, Administration of ceralasertib, Administration of ceralasertib and olaparib, Administration of ceralasertib in combination with olaparib NCT02264678 ACTIVE_NOT_RECRUITING A Modular Phase I, Open-Label, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumour Activity of Ceralasertib in Combination With Cytotoxic Chemotherapy and/or DNA Damage Repair/Novel Anti-cancer Agents in Patients With Advanced Solid Malignancies. 2026-06-30
: Dendritic Cell Vaccine NCT05809752 ACTIVE_NOT_RECRUITING A First in Human Dose Escalation of Dendritic Cell Vaccine (DCV) Administered Intrathecally (IT) Primed Against HER2/HER3 in Patients With Leptomeningeal Disease (LMD) From Triple-Negative Breast Cancer (TNBC) or HER2+ Breast Cancer (HER2+BC) 2026-08
Endoxifen Hydrochloride NCT03317405 ACTIVE_NOT_RECRUITING Phase I Trial of Endoxifen Gel Versus Placebo Gel in Women Undergoing Breast Surgery 2026-08-12
AVA6000 NCT04969835 RECRUITING A Phase 1, Open Label, Dose-Escalation and Expansion Study to Evaluate the Safety, Pharmacokinetics and Initial Therapeutic Activity of AVA6000, a Novel FAP-activated Doxorubicin Administered Intravenously in Patients With Locally Advanced or Metastatic Selected Solid Tumours 2026-08-15
Phase 2 Clinical Trials within 3 Months of Primary Completion Date:
DRUGNCTIDStatusClinical Trial NameCompletion Date
BB-1701 NCT06188559 COMPLETED An Open-label, Multicenter, Phase 2 Dose Optimization and Expansion Study to Evaluate the Safety and Efficacy of BB-1701, an Anti-human Epidermal Growth Factor Receptor 2 (Anti-HER2) Antibody-drug Conjugate (ADC), in Previously Treated Subjects With HER2-positive or HER2-low Unresectable or Metastatic Breast Cancer 2026-03-18
Patritumab deruxtecan NCT05865990 COMPLETED Multicenter, Single-arm, 3 Cohort, Phase II Trial of HER3-DXd in Patients With Active Brain Metastases From Metastatic Breast Cancer and Non-small Cell Lung Cancer, and in Patients With Leptomeningeal Disease From Advanced Solid Tumors 2026-04-03
Capecitabine, Trastuzumab, Vinorelbine NCT04296162 COMPLETED A Phase II Study to Assess the Effectiveness and Safety of Oral Vinorelbine or Capecitabine Combined With Trastuzumab as Adjuvant Treatment for Patients With Lymph Node Negative, HER-2 Positive and Small Tumor Size Breast Cancer (ORCHID) 2026-04-25
trifluridine/tipiracil NCT04489173 COMPLETED A Phase 2 Study of Trifluridine/Tipiracil in Patients With ER-positive, HER2-negative Advanced Breast Cancer That Previously Received Chemotherapy 2026-05-19
Fulvestrant, Letrozole, Exemestane, Denifanstat, Paclitaxel, Anastrozole, : Trastuzumab NCT03179904 ACTIVE_NOT_RECRUITING MC1633 Phase II Trial to Evaluate the Efficacy of the FASN Inhibitor, TVB-2640, in Combination With Trastuzumab Plus Paclitaxel or Endocrine Therapy in Patients With HER2+ Metastatic Breast Cancer Resistant to Trastuzumab-Based Therapy 2026-06-13
Paclitaxel NCT04090398 ACTIVE_NOT_RECRUITING Phase II Trial of Radium-223 Dichloride in Combination With Paclitaxel in Patients With Bone Metastatic Breast Cancer 2026-06-30
Halneuron, Halneuron (Open Label Extension) NCT06848348 RECRUITING A Randomized, Double-Blind, Placebo Controlled, Multicenter Study With Optional Open-Label Extension to Evaluate the Efficacy and Safety Study of Halneuron in the Treatment of Chemotherapy-Induced Neuropathic Pain 2026-08
Abemaciclib NCT04305834 RECRUITING A Phase IIA Trial Assessing the Tolerability of Abemaciclib in Combination With Endocrine Therapy in Patients Age 70 and Older With Hormone Receptor Positive Metastatic Breast Cancer Who Have Progressed on or After Prior CDK 4/6 Inhibition 2026-08-21
Phase 3 Clinical Trials within 3 Months of Primary Completion Date:
DRUGNCTIDStatusClinical Trial NameCompletion Date
Goserelin Acetate, Exemestane, Goserelin, Entinostat NCT02115282 ACTIVE_NOT_RECRUITING A Randomized Phase III Trial of Endocrine Therapy Plus Entinostat/Placebo in Patients With Hormone Receptor-Positive Advanced Breast Cancer 2026-06-02
Carboplatin, Eribulin, Capecitabine, SKB264, Nab-paclitaxel, Paclitaxel NCT06279364 RECRUITING A Randomized, Open-Label, Multicenter Phase 3 Study of SKB264 Versus Investigator's Choice Chemotherapy as First-Line Treatment in Patients With Unresectable Recurrent or Metastatic Triple-Negative Breast Cancer 2026-07
Eribulin, Gemcitabine, Dato-DXd, Capecitabine, Vinorelbine NCT05104866 ACTIVE_NOT_RECRUITING A Phase-3, Open-Label, Randomized Study of Dato-DXd Versus Investigator's Choice of Chemotherapy (ICC) in Participants With Inoperable or Metastatic HR-Positive, HER2-Negative Breast Cancer Who Have Been Treated With One or Two Prior Lines of Systemic Chemotherapy (TROPION-Breast01) 2026-07-31
Phase 4 Clinical Trials within 3 Months of Primary Completion Date:
DRUGNCTIDStatusClinical Trial NameCompletion Date
Daflon (Diosmin and Hesperidin) NCT07588828 COMPLETED EFFECT OF DAFLON (DIOSMIN AND HESPERIDIN) ON POST-OPERATIVE SEROMA FORMATION IN BREAST CANCER SURGERY 2026-04-15
NOTICE: This communication may contain confidential or proprietary information of Oncology Reference, Inc. Data is compiled from publicly available and third-party sources and integrated with proprietary Oncology Reference database mappings, developed and maintained by PhD scientists and advanced AI systems, for organization and analysis. While reasonable efforts are made to ensure accuracy and timeliness, Oncology Reference, Inc. makes no representation or warranty, express or implied, regarding accuracy, completeness, or fitness for a particular purpose. Information may contain errors, omissions, or be subject to change without notice. This material is for informational purposes only and is not medical advice, regulatory guidance, investment advice, or a substitute for professional judgment. Users must independently verify all information.

Oncology Reference, Inc. and its affiliates disclaim all liability for any loss or damage arising from use of or reliance on this information. By using this information, you agree that disputes will be governed by Delaware law and resolved by binding arbitration in Delaware.
California residents waive California Civil Code § 1542. All trademarks are the property of their respective owners.
© 2025 Oncology Reference, Inc. All rights reserved.

CONFIDENTIALITY NOTICE: If you are not the intended recipient, please notify the sender, delete this message, and refrain from using or disclosing its contents.